TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate CardiovascularOutcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control - TECOS

Conditions: Type 2 diabetes mellitus (T2DM)
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2008-006719-20-SK

Lead Sponsor: Merck & Co., Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 14000

Inclusion Criteria

a. Patient has T2DM with HbA1c of = 6.5% (48 mmol/mol) and = 8.0% (64 mmol/mol)
(HbA1c must be documented within 3 months prior to study enrollment) while
receiving metformin, pioglitazone, or a sulfonylurea as monotherapy or any dual
combination of metformin, pioglitazone, or a sulfonylurea continuously without
alteration in dose for at least 3 months OR
a stable dose of insulin (±20% of the scheduled total daily insulin dose) either
alone or in combination with a stable dose of metformin for at least 3 months
b. Patient is able to see a usual care provider at least twice a year
c. Patient is = 50 years of age with preexisting vascular disease, defined as having any one of the following:
c.1 History of a major clinical manifestation of coronary artery disease (i.e.,
myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary
revascularization procedure, or coronary angiography showing at least one
stenosis = 50% in a major epicardial artery or branch vessel);
c.2 Ischemic cerebrovascular disease, including:
c.2.1 History of ischemic stroke. Strokes not known to be hemorrhagic will be allowed as part of this criterion;
c.2.2 History of carotid arterial disease as documented by = 50 % stenosis
documented by carotid ultrasound, magnetic resonance imaging (MRI), or
angiography, with or without symptoms of neurologic deficit.
c.3 Atherosclerotic peripheral arterial disease, as documented by objective evidence
such as amputation due to vascular disease, current symptoms of intermittent
claudication confirmed by an ankle-brachial pressure index or toe brachial
pressure index less than 0.9 or history of surgical or percutaneous
revascularization procedure.
d. Female patients agree to use an effective method of contraception or must not
otherwise be at risk of becoming pregnant.
e. Patient understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing
written informed consent.
f. Patient agrees to provide permission to obtain all medical records necessary for
complete data ascertainment during the follow-up period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
b. Patient has a history of =2 episodes of severe hypoglycemia during the 12 months
prior to enrollment. Severe hypoglycemia (hypoglycemia requiring assistance) refers
to instances in which the patient was sufficiently disoriented or incapacitated as to
require help from either another individual or from medical personnel (whether or not
this assistance was actually provided).
c. Patient has taken an approved or investigational DPP-4 inhibitor agent (e.g.,
sitagliptin, alogliptin, saxagliptin, or vildagliptin), or GLP-1 analogue (e.g.,
exenatide, exenatide LAR, or liraglutide), or a thiazolidinedione other than
pioglitazone within the past 3 months.
d. Patient has cirrhosis of the liver, as assessed by medical history.
e. Patient is enrolled in another experimental protocol which involves the use of an
investigational drug or device, or an intervention that would interfere with the
conduct of the trial.
f. Patient has a planned or anticipated revascularization procedure.
g. Pregnancy or planned pregnancy during the trial period.
h. Patient has medical history that indicates a life expectancy of < 2 years or might limit the individual’s ability to take trial treatments for the duration of the study.
i. Patient has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose a risk to the patient, make participation not in the patient’s best interest, confound the results of the study (e.g., if patient cannot comply with requirements of the study), or interfere with the patient’s participation for the full duration of the study.
j. Patient has an estimated GFR (calculated based on serum creatinine via the MDRD
formula) of < 30 mL/min/1.73 m2.
k. Patient has a known allergy or intolerance to sitagliptin.
l. Patient has previously been enrolled in this trial.